Overview
The Clinical Development Director - Hepatology provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will work within project teams to plan, execute, and deliver activities including hepatology translational and clinical development strategies and clinical studies, particularly within the area of steatotic liver disease (SLD). You will work cross-functionally to develop and execute clinical development plan(s) up to, and including, Proof of mechanism/Proof of concept studies.
This role will provide you the opportunity to lead key activities to progress your career; these responsibilities include some of the following:
Responsibilities
* Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP. Develop sections of core regulatory documents.
* Generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
* Define and deliver the clinical pillars of the translational table. Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
* Seek and maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
* Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.
Clinical Development Strategy; Study & Program Design
* Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
* Contribute to the study team discussions on indication planning, incorporating input from across disciplines to contribute to vital deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
* Design clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input (e.g. patients, evidence generation, regulators, payors, pharmacovigilance).
* Develop clinical study protocols, amendments, investigator brochures, clinical study reports etc.
* Inputs to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
* Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician. If physician, accountability for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
Clinical Leadership
* Accountable for leading the CMT on an EPU program. Serves as a clinical point of contact both internally and externally for an indication of an asset indication or for a clinical study. Represents the clinical matrix team at EDT or clinical study at CMT.
* Collaborate with cross-functional teams to ensure cohesive and comprehensive translational and clinical development plans. Act as Clinical Lead at study level.
* Actively leads the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as the primary point of contact for an investigational agent or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
* Serves as the primary clinical interface with the RIIRU/GSK review boards.
* Clinical evaluation of business development opportunities.
* Stays abreast of advancements in hepatology research, trial methodologies, regulatory space to maintain GSK’s competitive edge. Identifies and highlights transformational opportunities where projects can offer significant benefit to patients.
* Gathers and supports integration of inputs from across disciplines to contribute to clinical components of the Medicine Profile. Contributes to solving study and development plan problems.
* Contributes to the implementation of strategic initiatives in the EPU.
* Demonstrates ability to influence others at project, department and inter-departmental levels as appropriate.
Influencing and Inspiring Others; Managing Conflict
* Able to consistently inspire others by setting a positive example and creating an environment where team members feel valued and motivated.
* Demonstrated experience in managing conflicts effectively and independently, negotiating mutually acceptable solutions.
* Employs strong influencing skills to gain support through understanding perspectives and building trust.
Enterprise Mindset and Navigating Ambiguity
* Demonstrated flexibility and adaptability in changing environments, able to analyze incomplete information, identify risks and make informed decisions.
* Demonstrated enterprise mindset with effective collaboration across the matrix; integrates cross-functional knowledge into decision-making and balances team objectives with wider business goals.
* Embraces challenge as an opportunity for creativity and uses new learning and digital tools to drive innovation.
* Proactively generates ideas for improvement and fosters an environment for others to do the same.
Qualifications
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
* PhD or PharmD (or equivalent) with 1-3 years postgrad experience in a relevant postgraduate training or job.
* Minimum of 3 years of experience in clinical research and development (may include postgrad experience).
* Knowledge of and experience in the execution of translational studies including generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems.
* Robust knowledge of hepatology specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
* Experience working with global regulatory agencies and managing global clinical trials in hepatology.
* Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
* Medical Degree Preferred
* Board certified/eligible in hepatology
* General internal medicine preferred for MDs or alternative experience in the relevant disease area
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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